COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction

NCT02509832 | Completed DMC

• 1 other identifier: EDC-2420
• Study Type: interventional
• Target: 100
• Locations: 7 countries
• Sites: 11

Brief Summary

COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction. Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.

Conditions

Acute Myocardial Infarction

Keywords

Therapeutic Hypothermia (TH); Acute Myocardial Infarction (AMI); Percutaneous Coronary Intervention (PCI)

Outcome Measures

Primary Outcomes (1)

• Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period

  30 day

Secondary Outcomes (1)

• 1. Anterior Infarct Size (IS) as assessed by Cardiac Magnetic Resonance (cMR) at 4 - 6 days following the index procedure for subjects in Test and Control Arms

  4 - 6 days

Study Arms (2)

Cooling + PCI

OTHER

The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Proteus IVTM System before and after PCI.

Device: Cooling + PCI

PCI only

OTHER

The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only.

Device: PCI only

Interventions

Cooling + PCI DEVICE

Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)

Cooling + PCI

PCI only DEVICE

Standard of Care for PCI

PCI only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age.
• symptoms consistent with AMI (chest pain, unresponsive to nitroglycerin, ≥ 30 minutes and \< 6 hours.
• Anterior MI with ST-segment elevation of 0.2 mV in two or more anterior contiguous precordial leads.
• Eligible for PCI.
• Opportunity for at least 10 minutes of cooling with the Proteus IVTM System prior to PCI.
• Written, informed consent to participate in this clinical trial.

You may not qualify if:

• Previous myocardial infarction.
• Cardiogenic shock (systolic blood pressure \[SBP\] \<80 mmHg and non-responsive to fluids, or SBP \<100 mmHg with vasopressors, or requirement for an intra-aortic balloon pump \[IABP\]).
• Resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class II through IV
• Aortic dissection or requires an immediate surgical or procedural intervention other than PCI
• Congestive Heart Failure (CHF), hepatic failure, end- stage kidney disease or severe renal failure (clearance \< 30ml/min/1.73m2).
• Fever (temperature \> 37.5 °C) or infection with fever in the last 5 days.
• Previous CABG.
• Stroke within 90 days of admission.
• Cardio-pulmonary decompensation present or imminent
• Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans)
• Hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• History of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
• Height of \<1.5 meters (4 feet 11 inches).
• Hypersensitivity to buspirone hydrochloride or Pethidine (Meperidine) and/or treatment with a monoamine oxidase inhibitor in the past 14 days.
• History of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the physician would be incompatible with Pethidine administration.

Sponsors & Collaborators

• ZOLL Circulation, Inc., USA: lead

Study Sites (13)

Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien

Vienna, Austria

Location

North Estonia Medical Center

Tallinn, 13419, Estonia

Location

Heart Center Balatonfüred

Balatonfüred, 8230, Hungary

Location

Medical and Health Science Center University of Debrecen

Debrecen, 4032, Hungary

Location

Heart Institute University of Pecs

Pécs, H-7624, Hungary

Location

Medical University in Łódź, Bieganski Hospital

Lodz, Poland

Location

National Institute of Cardiology, Department of Interventional Cardiology & Angiology

Warsaw, 04628, Poland

Location

Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

Location

Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)

Belgrade, Serbia

Location

University Clinical Hospital Center Zemun

Zemun, Serbia

Location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Skane University Hospital Lund University

Lund, Sweden

Location

Essex Cardiothoracic Centre, Anglia Ruskin University

Basildon, Essex, United Kingdom

Location

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Michael Holzer

  Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien

  PRINCIPAL INVESTIGATOR

• Marko Noc

  University Medical Center Ljubljana Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 28, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

GB (1); ES (1); HU (3); SL (1); PL (3); SE (1); AU (1)